Squamous Cell Carcinoma of the Head and NeckUnilateralNCT00206752
Study of Unilateral Neck Irradiation in Patients With SCC of the Head and Neck
A study testing Radiation therapy and definitive external beam radiation in the ipsilateral neck in people with Squamous Cell Carcinoma of the Head and Neck, run by Beth Israel Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to assess the feasibility of avoiding opposite side neck radiation therapy in patients with clearly one side squamous cell cancer of the head and neck. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Head and Neck
- What is being tested?
- Radiation therapy and definitive external beam radiation in the ipsilateral neck
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Squamous cell carcinoma of the oral cavity or oropharynx, with the primary lesion >1 cm from the midline.
- Patient has no clinical or radiologic evidence of contralateral neck node metastases.
- No evidence of distant metastasis.
- No previous history of radiation therapy or chemotherapy
- performance status 0-2
- Age >= 18
- Signed informed consent
- Patients must be accessible for treatment and follow-up
Who cannot join
- HIV positive patients
- Pregnancy or any patients not practicing contraception
- Active tobacco or alcohol addiction (as assessed by medical caregiver)
- Serious comorbid disease which prevents delivery of full treatment including psychiatric disorders, cardiopulmonary disease, etc.
- Concomitant use of any trial anticancer therapeutic within 30 days of entry
- Uncontrolled hypertension
- Known hypersensitivity to mammalian cell-derived products
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Medical Center
New York, New York, 10003
About this study
Official title: A Randomized Prospective Evaluation of Unilateral/Ipsilateral Neck Irradiation in Selected Patients With Squamous Cell Carcinoma of the Head and Neck Who Are Managed by Radiation Therapy
The purpose of this study is to assess the feasibility of avoiding opposite side neck radiation therapy in patients with clearly one side squamous cell cancer of the head and neck. We aim to assess the reduction in treatment volume (amount of radiation therapy required), and the resultant xerostomia and mucositis, with the delivery of unilateral neck radiation therapy.
Read the detailed description
Patients will be treated with definitive external beam radiation plus/minus chemotherapy plus/minus neck dissection in the ipsilateral neck (post radiation). The primary site will be treated with definitive radiation therapy, or definitive surgery plus post-operative radiation therapy. Primary endpoints are loco-regional control, as well as quality of life, xerostomia, mucositis, and neck fibrosis.
Salivary evaluations shall be performed prior to the initiation of radiation therapy, during the second week of EBRT, and at the completion of radiation. Evaluations will also be conducted at 3, 6, and 12 months after the completion of EBRT.
Oral mucositis will be assessed prior to the initiation of EBRT and weekly during EBRT. Evaluations will also be conducted at 3 and 6 months after the completion of EBRT. Two standardized mucositis scales will be used: the RTOG scale and the WHO scale.
Clinical response will be evaluated by physical exam and PET/CT. PET/CT scans will be done at 3, 6, 12, 18, and 24 months, and then when clinically indicated during follow-up.
- Being tested
- Radiation therapy, definitive external beam radiation in the ipsilateral neck
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation therapyRadiation
definitive external beam radiation in the ipsilateral neck.
definitive external beam radiation in the ipsilateral neckRadiation
definitive external beam radiation in the ipsilateral neck
| Study group | Role | What they receive |
|---|---|---|
| unilateral radiation therapy | Experimental | definitive external beam radiation in the ipsilateral neck. Receives: Radiation: Radiation therapy; Radiation: definitive external beam radiation in the ipsilateral neck |
What is being measured
The primary outcome is the main question the study is designed to answer.
FACT (head and neck);Xerostomia related Quality of Life Questionnaire
Measured: September 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startAug 2004
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of the Head and NeckStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kenneth Hu, MD, Principal investigator, Department of Radiation Oncology at Beth Israel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00206752
- Sponsor's protocol ID
- 186-03
- Other IDs
- ETH136-03D
- Acronym
- Unilateral
- Status last verified
- Mar 2015
- First submitted
- 13 Sep 2005
- Last updated
- 30 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Prospective Evaluation of Unilateral/Ipsilateral Neck Irradiation in Selected Patients With Squamous Cell Carcinoma of the Head and Neck Who Are Managed by Radiation Therapy
- ClinicalTrials.gov ID
- NCT00206752
- Acronym / sponsor ID
- Unilateral / 186-03
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Beth Israel Medical CenterUniversity, hospital or other
- Study start
- Aug 2004
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the feasibility of avoiding opposite side neck radiation therapy in patients with clearly one side squamous cell cancer of the head and neck. We aim to assess the reduction in treatment volume (amount of radiation therapy required), and the resultant xerostomia and mucositis, with the delivery of unilateral neck radiation therapy.
Detailed description
Patients will be treated with definitive external beam radiation plus/minus chemotherapy plus/minus neck dissection in the ipsilateral neck (post radiation). The primary site will be treated with definitive radiation therapy, or definitive surgery plus post-operative radiation therapy. Primary endpoints are loco-regional control, as well as quality of life, xerostomia, mucositis, and neck fibrosis.
Salivary evaluations shall be performed prior to the initiation of radiation therapy, during the second week of EBRT, and at the completion of radiation. Evaluations will also be conducted at 3, 6, and 12 months after the completion of EBRT.
Oral mucositis will be assessed prior to the initiation of EBRT and weekly during EBRT. Evaluations will also be conducted at 3 and 6 months after the completion of EBRT. Two standardized mucositis scales will be used: the RTOG scale and the WHO scale.
Clinical response will be evaluated by physical exam and PET/CT. PET/CT scans will be done at 3, 6, 12, 18, and 24 months, and then when clinically indicated during follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| unilateral radiation therapy | Experimental | Radiation: Radiation therapy, Radiation: definitive external beam radiation in the ipsilateral neckdefinitive external beam radiation in the ipsilateral neck. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Squamous cell carcinoma of the oral cavity or oropharynx, with the primary lesion >1 cm from the midline.
- Patient has no clinical or radiologic evidence of contralateral neck node metastases.
- No evidence of distant metastasis.
- No previous history of radiation therapy or chemotherapy
- performance status 0-2
Key exclusion criteria (7 listed)
- HIV positive patients
- Pregnancy or any patients not practicing contraception
- Active tobacco or alcohol addiction (as assessed by medical caregiver)
- Serious comorbid disease which prevents delivery of full treatment including psychiatric disorders, cardiopulmonary disease, etc.
- Concomitant use of any trial anticancer therapeutic within 30 days of entry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation therapydefinitive external beam radiation in the ipsilateral neck. | Radiation | unilateral radiation therapy |
| definitive external beam radiation in the ipsilateral neckdefinitive external beam radiation in the ipsilateral neck | Radiation | unilateral radiation therapy |
Primary outcome
FACT (head and neck);Xerostomia related Quality of Life Questionnaire
Time frame: September 2010
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Hu, MD principal investigator
Department of Radiation Oncology at Beth Israel Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiation therapy and definitive external beam radiation in the ipsilateral neck in people with Squamous Cell Carcinoma of the Head and Neck, run by Beth Israel Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FACT (head and neck);Xerostomia related Quality of Life Questionnaire (time frame: September 2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2015.